Fingolimod (By mouth)
Reduces frequency of flare-ups (relapses) in people who have multiple sclerosis (MS).
Brand Name(s):There may be other brand names for this medicine.
When This Medicine Should Not Be Used:You should not use this medicine if you have had an allergic reaction to fingolimod.
How to Use This Medicine:
- Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
- You may take this medicine with or without food.
- This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one. Your doctor might ask you to sign some forms to show that you understand this information.
If a dose is missed:
- If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.
How to Store and Dispose of This Medicine:
- Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
- Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
- Keep all medicine away from children and never share your medicine with anyone.
Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.
- Make sure your doctor knows if you are also using ketoconazole (Nizoral®), medicine for heart rhythm problem (such as amiodarone, procainamide, quinidine, sotalol, Betapace®, Cardioquin®, Cordarone®, Procanbid®, or Quinaglute®), or certain blood pressure medicine (such as atenolol, diltiazem, metoprolol, propranolol, Cardizem®, Inderal®, Tenormin®, or Toprol®).
- Make sure your doctor knows if you are receiving a medicine that causes a weak immune system. This may include cancer medicines or other medicines for multiple sclerosis (such as mitoxantrone, natalizumab, Novantrone®, or Tysabri®).
- Talk to your doctor before getting flu shots or other vaccines while you are receiving this medicine. Vaccines may not work as well, or they could make you ill while you are using this medicine.
Warnings While Using This Medicine:
- Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. You should not become pregnant while you are taking this medicine and for 2 months after stopping it. If you think you have become pregnant while using the medicine, tell your doctor right away. Your doctor may want you to join a pregnancy registry for patients taking this medicine.
- Make sure your doctor knows if you are breastfeeding, or if you have kidney disease, liver disease, heart disease, congestive heart failure, heart rhythm problems (such as arrhythmia, heart block, sick-sinus syndrome, prolonged QT interval), high blood pressure, slow heartbeat, or a history of fainting spells. Tell your doctor if you have breathing problems, diabetes, a history of eye problems (such as uveitis), any infection, or have had chickenpox.
- This medicine may cause your heart rate to slow down, especially after taking the first dose. You will be observed in a hospital or clinic for 6 hours for signs and symptoms of bradycardia (slow heartbeat). Symptoms may include chest pain or discomfort; ightheadedness, dizziness, or fainting; shortness of breath; slow or irregular heartbeat; or unusual tiredness.
- Fingolimod can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
- You should receive a varicella zoster virus (VZV) vaccine for at least 1 month before starting treatment with this medicine, especially if you have not had chickenpox. Ask your doctor if you have any questions.
- This medicine may cause macular edema (swelling of the back of the eye), especially during the first 3 to 4 months of treatment. Check with your doctor immediately if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an eye doctor.
- Stop using this medicine and check with your doctor right away if you have shortness of breath, difficult or labored breathing, tightness in the chest, or wheezing while taking this medicine.
- Stop using this medicine and check with your doctor right away if you have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.
- Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments. Blood tests and tests for heart function may be needed to check for unwanted effects.
Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:
- Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
- Blurred vision or other vision changes.
- Dark-colored urine or pale stools.
- Fever, chills, cough, sore throat, and body aches.
- Nausea, vomiting, loss of appetite, or pain in your upper stomach.
- Shortness of breath or troubled breathing.
- Slow or uneven heartbeat.
- Yellowing of your skin or the whites of your eyes.
If you notice these less serious side effects, talk with your doctor:
- Back pain.
- Feeling depressed.
- Headache or dizziness.
- Stuffy or runny nose
If you notice other side effects that you think are caused by this medicine, tell your doctor
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088Last Updated:
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